—#107459

Product

Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K990214
Affected lot / code info: Part Number 962011S: Lot Numbers 090106, 071219

Why it was recalled

When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra.

Root cause (FDA determination)

Device Design

Action the firm took

An Urgent - Product Safety Notice customer letter was sent via FED EX on 2/6/12 and 2/6/12 to direct consignees in the US identifying the affected product and the issue with it. The letter states that Medtronic Navigation is removing the product from clinical use and will provide a sales credit to customers. In the letters to Medtronic field personnel, it states that local sales and service personnel will be identified to remove the affected product from customer sites and return them for scrapping. Customers are to contact a sales representative if they have any questions regarding the letter.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Worldwide Distribution -- US and Republic of South Korea.

Timeline

Recall initiated: 2012-02-06
Posted by FDA: 2012-03-08
Terminated: 2012-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.